MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 304

Model Number 304-20

Device Problem High impedance (1291)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/18/2015

Event Type  malfunction  

Event Description

Clinic notes were received indicating that the vns patient's device showed a high impedance condition during an office visit on (b)(6) 2015.Lead impedance was found to have increased (impedance value >= 10,000 ohms) at the patient's next office visit on (b)(6) 2016.No known surgical interventions have occurred to date.

Event Description

The patient underwent generator and lead replacement on (b)(6) 2016.The explanted generator and lead were received for analysis.Analysis is underway, but has not been completed to date.

Event Description

Product analysis evaluated the explanted lead and generator.The lead was returned as one portion with the pin however the electrodes were not attached and therefore they could not be evaluated.Lab analysis confirmed an abraded opening on the outer tubing.Dried fluid was identified in the inner tubing of the negative coil.Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.Analysis found that the battery was at ifi = no.The generator was able to successfully interrogate and perform system diagnostic tests in the pa lab.During comprehensive automated electrical testing the generator performed to functional specifications.

• Brand Name: LEAD MODEL 304
• Type of Device: LEAD
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 5467412
• MDR Text Key: 39654247
• Report Number: 1644487-2016-00444
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2016
• Device Model Number: 304-20
• Device Lot Number: 202126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 02/18/2016
• Initial Date FDA Received: 02/29/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/13/2016; 05/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 6 YR